Is NCT05943496 recruiting in Portland, OR?

Yes, NCT05943496 is currently recruiting participants at its Portland, OR location. This chronic lymphocytic leukemia clinical trial is actively enrolling qualified participants.

How do I join the chronic lymphocytic leukemia clinical trial in Portland?

To join this clinical trial in Portland, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Portland clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Chronic Lymphocytic Leukemia Clinical Trial in Portland, OR

About This Chronic Lymphocytic Leukemia Study in Portland

This phase Ib trial tests the safety and effectiveness of tafasitamab, acalabrutinib, and obinutuzumab in treating patients with previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). CLL and SLL are types of cancer that develops from a specific white blood cell called B cells or B lymphocytes. Tafasitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell cancers such as CLL at abnormal levels. This may help keep cancer cells from growing and spreading. Giving tafasitamab, acalabrutinib, and obinutuzumab may kill more cancer cells in patients with previously untreated CLL and SLL.

Sponsor: OHSU Knight Cancer Institute

Who Can Participate

Inclusion Criteria

Written informed consent. Participant or legally authorized representative (LAR) must provide written informed consent prior to any study-specific procedures or interventions

Age \>= 18 years. All genders, races, and ethnic groups will be included

Ability to swallow and retain oral medication

Documented previously untreated CLL/SLL. Diagnosis must be confirmed by peripheral blood flow cytometry or lymph node biopsy and made in accordance with international workshop (iw)CLL diagnostic criteria

Baseline detectable immunoglobulin heavy (IGH) gene signature determined as part of clonoSEQ for minimal residual disease (MRD) testing

Must meet at least 1 criterion for treatment based on iwCLL guidelines

Evidence of progressive marrow failure as manifested by the onset or worsening of anemia and/or thrombocytopenia, or

Massive (i.e., lower edge of spleen \>= 6 cm below the left costal margin), progressive, or symptomatic splenomegaly, or

Massive (i.e., \>= 10 cm in the longest diameter), progressive, or symptomatic lymphadenopathy, or

Progressive lymphocytosis in the absence of infection, with an increase in blood absolute lymphocyte count (ALC) \> 50% over a 2 month period, or lymphocyte doubling time of \< 6 months (as long as initial ALC was \>= 30,000/uL), or

Autoimmune anemia and / or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy, or

Constitutional symptoms, defined as any one or more of the following disease related symptoms or signs occurring in the absence of evidence of infection:

Unintentional weight loss of \>= 10% within the previous 6 months, or

Significant fatigue (grade \>= 2), or

Fevers \> 100.5°F or 38.0°C for \>= 2 weeks, or

Night sweats for \> 1 month FOR PARTICIPANTS WITH SLL ONLY:

Presence of measurable lymphadenopathy, defined as the presence of ≥ 1 nodal lesion that measures ≥ 2.0 cm in the longest diameter (LD) and ≥ 1.0 cm in the longest perpendicular diameter (LPD) as assessed by computed tomography (CT) or magnetic resonance imaging (MRI)

Eastern Cooperative Oncology Group (ECOG) performance status =\< 2

Life expectancy of greater than 12 months, as estimated by the treating physician or investigator

Absolute neutrophil count (ANC) \> 1,000/mm\^3 (uL)

Platelet count \> 50,000/mm\^3 (uL).

Serum creatinine =\< 2 x upper limit of normal (ULN) or creatinine clearance (CrCl) \>= 40 mL/min by Cockcroft-Gault

Aspartate aminotransferase (AST) =\< 3 x ULN

Alanine aminotransferase (ALT) =\< 3 x ULN

Alkaline phosphatase (ALP) =\< 3 x ULN

Total bilirubin =\< 2.5 x ULN unless documented history of Gilbert's syndrome

Negative for hepatitis C infection and chronic hepatitis B infection

Participants with positive serology for hepatitis C virus (HCV) must have been tested for HCV ribonucleic acid (RNA) and are eligible only in the case of negative HCV RNA by polymerase chain reaction (PCR) testing

Participants must be hepatitis B virus (HBV) negative by serology. Participants with occult or prior HBV infection (defined as negative hepatitis B \[HB\] surface antigen \[sAg\] and positive serology testing for anti-HBV core antigen \[cAb\]) may be included if HBV deoxyribonucleic acid (DNA) was undetectable by PCR, provided that they are willing to undergo monthly ongoing DNA testing. Antiviral prophylaxis may be administered as per institutional guidelines

Participants who have protective HBV titers of HB surface antibody (sAb) (HBsAb positive, HBcAb negative, and HBsAg negative) after vaccination or previously cured hepatitis B are eligible

Individuals with childbearing potential must have documented negative pregnancy test within the 7 days before the start of any treatment drug and must commit to the use of study approved methods of contraception during study treatment and for 6 months after the last dose of obinutuzumab

Individuals that can contribute sperm for the conception of a child must commit to the use of study approved methods of contraception during the trial period and for 6 months after the last dose of obinutuzumab. Such individuals must also refrain from donation of sperm during study treatment and for 6 months after the last dose of obinutuzumab

Individuals of reproductive and lactating potential must agree to stop breastfeeding and refrain from donation of ova from the start of study treatment (cycle \[C\]1 day \[D\]1) and for 6 months after the last dose of obinutuzumab Participant

Exclusion Criteria

Previous or concurrent diagnosis of any other hematologic malignancy

Any previous CLL-directed treatment. Use of corticosteroids (or ongoing prednisone =\< 20 mg daily, or equivalent) for symptom control are permitted. Enrollment will be considered for those individuals that can taper ongoing use of a corticosteroid at \> 20 mg daily to 0 mg within 14 days after C1D1

Known history of hypersensitivity to

Humanized or murine monoclonal antibodies or products

A CD19 or CD20 antibody

Tafasitamab

Acalabrutinib

Receipt of live vaccine within 14 days of trial enrollment

Prior history of any solid malignancy, unless disease-free for over 2 years, exclusive of any prior history of squamous cell carcinoma of the skin or cervix, basal cell carcinoma of the skin, transitional cell urothelial carcinoma, prostate cancer, or early-stage melanoma. Exceptions will be considered, at the discretion of the investigator, if the prior treatment (i.e., within 2 years) is not expected to confound the results of this study

Patients with history of confirmed progressive multifocal leukoencephalopathy (PML)

Active autoimmune disease requiring treatment with \> 20 mg of prednisone (or prednisone equivalent daily), apart from autoimmune hemolytic anemia or immune thrombocytopenic purpura (ITP).

Evidence of ongoing systemic bacterial, fungal, or viral infection, except localized fungal infections of skin or nails. NOTE: Participants may be receiving prophylactic antiviral or antibacterial therapies at the discretion of the investigator

Seropositivity for, or history of active viral infection with, human immunodeficiency virus (HIV)

Known histological transformation from CLL to an aggressive lymphoma (i.e., Richter's transformation)

Known bleeding disorders

Use of warfarin, marcumar, or phenprocoumon unless drug can be discontinued with normalization of international normalized ratio (INR) (e.g., INR \< 2, or baseline) within 7 days of C1D1

Any participant having received agents known to be strong and moderate cytochrome P450 3A inhibitors or inducers within 7 days prior to screening / baseline may require special approval and / or a wash-out period before day 1, at the discretion of the investigator

Any severe and / or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:

Symptomatic, or history of documented congestive heart failure (New York \[NY\] Heart Association functional classification III-IV)

Left ventricular ejection fraction (LVEF) \< 50%

Poorly controlled atrial fibrillation

A history of ventricular arrhythmias

Uncontrolled hypertension (HTN): Defined as hypertension despite the use of \> 2 anti-HTN agents at optimal doses

Myocardial infarction within 6 months of enrollment

Angina not well-controlled by medication

Poorly controlled or clinically significant atherosclerotic vascular disease including cerebrovascular accident (CVA), transient ischemic attack (TIA), angioplasty, cardiac / vascular stenting within 6 months of enrollment

Any other significant medical illness, abnormality, or condition that would, in the investigator's judgement, make the participant inappropriate for study participation or would put the participant at risk

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Portland?

Yes, this clinical trial (NCT05943496) has an active research site in Portland, OR that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chronic Lymphocytic Leukemia Treatment Options in Portland, OR

If you're searching for chronic lymphocytic leukemia treatment options in Portland, OR, this clinical trial (NCT05943496) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Portland research site is actively enrolling participants for this clinical trial. You'll receive care from experienced chronic lymphocytic leukemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chronic lymphocytic leukemia clinical trials near you to find additional studies recruiting in your area.

Chronic Lymphocytic Leukemia Clinical Trial in Portland, OR

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